CartiHeal announced successful enrollment and surgery of the 100th patient in the pivotal study of the Agili-C™ implant.
The device is a porous, biocompatible and resorbable bi-phasic scaffold made of interconnected natural inorganic calcium carbonate.
The Investigational Device Exemption study commenced one year ago in the U.S., EU and Israel, and will support CartiHeal's pursuit of an FDA premarket approval application. Its objective is to demonstrate superiority of Agili-C vs. microfracture and debridement in osteoarthritic knees and knees without degenerative damage—mimicking the range observed by surgeons in clinics.
Agili-C has been implanted in >400 patients to treat OA in the knee, ankle and great toe, ranging from single focal lesions to multiple and large defects.